Orthopedic device providing metered toe traction with variable adduction, dorsiflexion and rotation angles, including lateral glide of the first metatarsal head

ABSTRACT

In device for placing a toe of a patient&#39;s foot in traction may broadly include a shoe portion (e.g., a sole, counter, and strap(s)); a toe attachment apparatus (e.g., a Chinese finger trap) having a cable extending therefrom; a pulley, with the cable wrapped about the pulley; and an apparatus (e.g., a ratchet, an actuator, and the like) configured to apply tension to the cable to create traction in the toe. A second actuator may adjust lateral positioning of the pulley relative to the shoe portion to set a desired angle of adduction for the traction provided to the toe by the cable. A meter may be coupled to the cable to indicate an amount of tension provided thereto. Another actuator may adjust elevational positioning of the pulley relative to the shoe portion to set a desired angle of dorsiflexion for the traction provided to the toe by the cable.

CROSS REFERENCES TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/162,777, filed on May 24, 2016, which claims priority on U.S.Provisional Application Ser. No. 62/172,934 filed on Jun. 9, 2015, thedisclosures of which are incorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates to apparatus for treating variousconditions of a person's toes, and more particularly to apparatus whichare capable of providing a measured amount of traction to a toe, whichmay be adjusted in terms of traction force and adduction, dorsiflexion,and medial and lateral rotation angles, in addition to lateral glide ofthe head of the first metatarsal head angle.

BACKGROUND OF THE INVENTION

There are many medical problems that affect the toes of a person's feet.A common problem is known colloquially as a bunion, and is termed HalluxAbducto Valgus within the medical community. Hallux Valgus, also knownas “Jaccoud's Arthropathy,” is characterized by progressivedeterioration of the first metatarsal (MT) joint of the great (big) toe.

Normal great, or big toe alignment is characterized by a Hallux ValgusAngle (HVA) of between 5 and 10 degrees of the long axis of the proximalphalanx bone of the toe relative to the long axis of the metatarsal boneat the metatarsophalangeal (MTP) joint. (Hart et al 2008). A clinicaldiagnosis of Hallux Valgus is made when this angle exceeds 15 degrees.The first phase of the disorder involves modest lateral drifting of thegreat toe (greater than 20 degrees) towards the other toes. This phaseis accompanied by early stage inflammation and swelling, which may gounnoticed as it is often relatively painless. However, the patient maybegin to notice the lateral drift, but the resultant aesthetic loss isminor.

The second phase begins with reddening and puffiness of the skin overthe metatarsal head. The skin soon becomes inflamed and scar tissueforms. The resulting bunion makes wearing narrow toed shoes, and manyother types of shoes, painful if not impossible. The second phase isalso characterized by mild to moderate pain, stiffness (hypomobility) ofthe metatarsal phalangeal joint (MTP) and further lateral drift of thegreat toe (HVA>30 degrees). The deformity becomes very noticeable, andpatients tend to find it acutely embarrassing.

The third phase is characterized by increasing lateral drift (HVA>40degrees—see FIG. 2 ) and further deformity. The bunion becomes large andpainful, and the toe becomes even more hypomobile (i.e., stiff), havinga diminished range of motion in all directions due to scarring anddecreased activity. The big toe may also suffer from arthritis. Thedrift deformity is now extreme and shoe options are severely limited tovery wide toe box shoes, which are decidedly unfashionable. Walking ispainful and the patient often seeks surgical intervention at this point.

It is generally agreed that certain inherited foot traits—flat feet,excessive ligamentous flexibility, abnormal bone structure, and somenerve conditions—may tend to make a person more susceptible todeveloping bunions, which is evidenced by appearance of the deformity inyounger individuals. However, hallux valgus is most prevalent in womenfrom western cultures, particularly women over the age of 35. So, whileexperts may be divided on whether ill-fitting footwear may beattributable as being the principle cause of bunions, it is agreed thatthe problem is at least exacerbated by prolonged wearing of high heeled,narrow toe box shoes. It may also be precipitated or compounded by footinjuries. Studies show that bunions are less prevalent in individualswho tend to go barefoot, while women are 10 time more likely to developbunions than are men, with this disparity lending further weight as tothe causation/exacerbation being attributable to the tendency of womento wear high-heeled, narrow-toes shoes. Bunions are also quite commonfor ballet dancers—individuals who are often plagued by foot injuries,and who also regularly wear tight leather or canvas slippers.

Current non-surgical treatment options now generally include custom-madeorthoses. However, a recent report shows that these “appear to have noeffect in the evolution of mild and moderate HV during a 12 month period. . . ” Reina M, Lafuente G, and Munuera PV, “Effect of Custom-made FootOrthoses in Female Hallux Valgus After One-year Follow Up,” Prostheticsand Orthotics International, April 2013; 37(2):113-9.

Another treatment option includes the use of custom insoles with toeseparators (night splints), however studies have shown that the use of a“night splint seems to have no effect on painful hallux valgusdeformity,” and “was not effective in improvement of the great toeangles . . . ” Tehraninasr A, Saeedi H, Forogh B, Bahramizadeh M, andKeyhani MR, “Effects of Insole with Toe-Separator and Night Splint onPatients with Painful Hallux Valgus: A Comparative Study,” Prostheticsand Orthotics International, March 2008; 32(1):79-83.

Treatment for a severe deformity may include surgery. However, before adeformity progresses to the severity that may only be countered withcorrective surgery, treatment nonetheless calls for the use of anorthopedic device. The present invention provides an improved orthopedicdevice that may be used for the treatment of hallux valgus, as well asother for other conditions (i.e., hammer toe, mallet toe, and claw toe).

OBJECTS OF THE INVENTION

It is an object of the invention to provide an orthotic device capableof placing one or more toes of a patient's foot in traction.

It is another object of the invention to provide an orthotic device inthe form of a shoe.

It is also object of the invention to provide a measured amount oftraction to the patient's toe or toes.

It is a further object of the invention to provide traction to one ormore toes of the patient and to be capable of adjusting the adduction,dorsiflexion, rotation angles thereto, and further capable of providinga lateral glide to the head of the metatarsal.

It is another object of the invention to provide an orthotic device thatthe patient may be capable of independently applying and wearing withoutthe assistance of a medical practitioner.

Further objects and advantages of the invention will become apparentfrom the following description and claims, and from the accompanyingdrawings.

SUMMARY OF THE INVENTION

This Summary is provided to introduce a selection of concepts in asimplified form that are further described below in the DetailedDescription. This Summary is not intended to identify key features oressential features of the claimed subject matter, nor is it intended tobe used to limit the scope of the claimed subject matter.

In accordance with at least one embodiment of the present invention, adevice for use in placing a toe of a patient's foot in traction maybroadly include a shoe portion; a toe attachment apparatus (e.g., aChinese finger trap, a finger stall, and the like); a cable having afirst end and a second end, the first end of the cable coupled to thetoe trap; a pulley, with the cable configured to wrap about the pulley;and an apparatus (e.g., a ratchet, an actuator that may be pneumatic,with a pressure gauge, and the like) configured to apply tension to thecable to create traction in the toe.

The device may also include an actuator that may be configured to adjustlateral positioning of the pulley relative to the shoe portion to set adesired angle of adduction for the traction provided to the toe by thecable. The device may also include a meter coupled to the cable andconfigured to indicate an amount of tension provided thereto by theratchet. The device may further include a second actuator configured toadjust elevational positioning of the pulley relative to the sole of theshoe portion to set a desired angle of dorsiflexion for the tractionprovided to the toe by the cable. Where a ratchet is used to applytension to the cable, the wheel of the ratchet may be configured toreceive a tool to actuate the ratchet. The wheel of the ratchet may havea fine set of teeth formed thereon to allow for small adjustment to bemade to the tension in the cable. The shoe portion of the device maybroadly include a sole; a counter configured to brace the back of thepatient's foot; and one or more straps configured to secure thepatient's foot within the shoe portion, to brace the foot with respectto the counter, using hook and loop materials (or a buckle) on the oneor more straps.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a top view of the bones of a normal foot.

FIG. 2 is a top view of the bones of a foot that is affected by halluxvalgus, resulting in an outward facing deformation of the big toe.

FIG. 3 is a side view of a first embodiment of a toe traction device ofthe present invention, which is capable of providing traction to apatient's toe using an adjustment of various angles of the toes.

FIG. 4 is a top view of the device of FIG. 3 .

FIG. 5 is a bottom view of the device of FIG. 3 .

FIG. 6 is a side view of an alternate embodiment of the toe tractiondevice of FIG. 3 .

FIG. 7 is top view of the device of FIG. 6 .

FIG. 8 is a bottom view of the device of FIG. 6 .

FIG. 9 is a perspective view of an alternate embodiment of the toetraction device of FIG. 6 .

FIG. 10 is a side view of the device of FIG. 9 .

FIG. 11 is a perspective view of an alternate embodiment of the deviceof FIG. 9 .

FIG. 12 is a perspective view of an alternate embodiment of the deviceof FIG. 11 .

FIG. 13 is a photograph showing a perspective view of a prototype of atoe traction device of the present invention.

FIG. 14 is a photograph showing a side view of the prototype tractiondevice of FIG. 13 .

FIG. 15 is a photograph showing a top view of the prototype tractiondevice of FIG. 13 .

FIG. 16 is a top view of an embodiment of a toe traction device of thepresent invention.

FIG. 17 is a top view of an alternate embodiment of the toe tractiondevice of FIG. 16 , which includes a tension meter.

FIG. 18 is a top view of another embodiment of the toe traction deviceof FIG. 17 , in which the ratchet may be driven by a separate removablehandle.

FIG. 18A is a side view of a handle that may be used with the toetraction device of FIG. 18 .

FIG. 19 is a top view of an alternate embodiment of the toe tractiondevice of FIG. 17 , in which a linear actuator may be used to adjust anangle of adduction for the traction provided to the toe.

FIG. 19A is a top view of an alternate embodiment of the toe tractiondevice of FIG. 19 , in which the ratchet has been replaced with a lineartype of actuator.

FIG. 20 is a top view of an alternate embodiment of the toe tractiondevice of FIG. 19 , in which a second linear actuator may also be usedto adjust a height of the device that provides traction to the toe.

FIG. 21 is a top view of an alternate embodiment of the toe tractiondevice of FIG. 20 , in which a metered tension wrench is coupled to theratchet to provide a direct means for applying a desired amount oftraction to the toe.

FIG. 22 illustrates a side perspective view of another embodiment of atraction apparatus of the present invention.

FIG. 23 shows a second side perspective view of the traction apparatusshown in FIG. 22 .

FIG. 24 is an exploded view showing the component parts of the tractionapparatus of FIG. 22 .

FIG. 25 is a front view of the traction apparatus of FIG. 22 .

FIG. 26 is a rear view of the forward portion of the traction apparatusof FIG. 22 , with the slidable adjustment plate shown at a lowerposition.

FIG. 27 is a rear view of the forward portion of the traction apparatusof FIG. 22 , with the slidable adjustment plate shown at an elevatedposition.

FIG. 28 is a top perspective view of the traction apparatus of FIG. 22 ,with the arm positioned on a first side of the apparatus.

FIG. 29 is the top perspective view of FIG. 28 , but shown with the armpositioned on a second side of the apparatus.

FIG. 30 illustrates a side perspective view of another embodiment of thetraction apparatus of FIG. 22 , which includes a clamp device.

FIG. 31 illustrates a top perspective view of the traction apparatus ofFIG. 30 .

FIG. 32 illustrates a front perspective view of an alternate embodimentof the traction apparatus of FIG. 30 , which includes a block that isreleasably securable to the sole of the shoe, and has a vertical surfacethat may be suitably positioned to impart a lateral force to the head ofthe first Metatarsal bone.

FIG. 33 is the front perspective view of FIG. 32 , but showing the blockrotated 180 degrees so that an angled surface thereon may be used toimpart rotation to the proximal phalangeal bone of the great toe.

FIG. 34 is a top view of the sole of the shoe of the traction apparatusof FIGS. 33-33 , showing a pegboard or area for application of Velcrothat may be used to selectively position the block thereon.

DETAILED DESCRIPTION OF THE INVENTION

As used throughout this specification, the word “may” is used in apermissive sense (i.e., meaning having the potential to), rather thanthe mandatory sense (i.e., meaning must). Similarly, the words“include”, “including”, and “includes” mean including but not limitedto.

The phrases “at least one”, “one or more”, and “and/or” are open-endedexpressions that are both conjunctive and disjunctive in operation. Forexample, each of the expressions “at least one of A, B and C”, “one ormore of A, B, and C”, and “A, B, and/or C” mean all of the followingpossible combinations: A alone; or B alone; or C alone; or A and Btogether; or A and C together; or B and C together; or A, B and Ctogether.

Also, all references (e.g., patents, patent application publications,and non-patent literature) that are cited within this documents areincorporated herein in their entirety by reference.

Furthermore, the described features, advantages, and characteristics ofany particular embodiment disclosed in the following specification, maybe combined in any suitable manner with any of the other embodimentsdisclosed herein.

FIG. 3 shows a side view of a toe traction shoe/device 10 of the presentinvention. It should be noted at the outset that each embodiment of theapparatus described herein is configured to be secured to the patient'sfoot, and several embodiments being compactly configured may closelyresemble a shoe or sandal. However, although it may be possible, thepatient would not likely be walking about while wearing the device toapplying traction to one of his/her toes. Therefore, throughout thisdocument, the terms “shoe” and “device” are used interchangeably,without intending to detract from the advantageously compactconfiguration of those particular shoe-like embodiments.

Toe traction shoe 10 may include a sole portion 20, which may extendfrom a first end 21 to a second end 22. Extending upwardly from thesecond end 22 of the sole 20 may be a counter 23 that may be used tobrace the back of the foot 5. One or more straps may be used to securethe foot 5 within the shoe 10, to brace the foot with respect to thesole to permit traction to be applied to one of the toes. In thisembodiment, a single strap 24 may be used to secure the foot withrespect to the counter 23. One end of the strap 24 may be fixedlyconnected to a first side of the shoe 10, and the other end of the strapmay be adjustably connected to a second side of the shoe using Velcro®(i.e., respective hook and loop fastening materials), or using a buckle,or using any other securing means known in the art. Alternatively, twostraps may be used, where each strap has a first end fixedly connectedto a respective side of the shoe, and the second ends of the straps arereleasably coupled together using the Velcro materials (e.g., 224Vh and224VL in FIG. 9 ).

To treat a hallux valgus condition, traction would necessarily beapplied to the big toe. Therefore, without intending this specificationto be so limiting, the remainder of the discussion is directed toapplying traction to the big toe. However, it may be understood that thepresent invention may furthermore be constructed and adjusted to beutilized for applying traction to any one, or more, of the differenttoes of a patient's foot.

A toe of the patient's foot (e.g., the big toe) may receive anattachment means thereon, which may be used for applying tension to thattoe. The attachment means may simply be a first string (or a cable,elastomeric member, rubber band, etc.), and a second such string ormember being secured to opposite sides of the toe using medical tape.The attachment means may also be in the form of the “Extension Bandage”taught by U.S. Pat. No. 1,268,932 to Corrigan. The attachment means mayalso be any one of the devices/finger traps taught by U.S. Pat. No.2,688,961 to Thomas, U.S. Pat. No. 3,872,861 to Tamny, and U.S. Pat. No.5,451,203 to Lamb, and the like. The “Finger Trap” of the '861 patent toTamny may be used on the toes of the patient herein, as it is known tosimply be a plurality of strands braided together in a substantiallycylindrical form, so that when the end of a central strand or strands ispulled, it results in a contraction of the diameter of the cylinder andclamping upon the digit of the patient.

The toe trap 27 shown in FIG. 3 may terminate in a single strand orcable 28, which when pulled may cause contraction of the trap upon thetoe of the patient. The strand 28 may wrap around a first pulley 29 tobe directed downwardly, and may then wrap around part of a second pulley30, to be directed rearward with respect to shoe 10. The pulleys 29 and30 may each be rotatably mounted to a support bracket 31 that mayprotrude forward of the shoe 10. The strand 28 may be coupled to atension meter, which may be used to indicate the amount of tractionbeing applied to the toe of the patient. Such tension meters are shown,for example, by U.S. Pat. No. 1,650,603 to Burton, and U.S. Pat. No.2,925,734 to Gorgens. A ratchet arrangement 34 may be actuated by anAllen key or other tool 35 to add tension to the strand 28. Anotherstrand 28A may couple the other side of the tension meter to a gearedtensioning handle 38, with the strand being directed thereto by pulleys36 and 37, each of which may be rotatably mounted to another supportbracket. The handle 38 may be turned to add tension in the cables 28 and38. Rather than a geared tensioning handle, the handle may be coupled toa screw actuator that may adjust the positioning of the end of the cablewith respect to pulley 37 (e.g., rotating the handle to decreasetension, and counter-rotating to increase tension). The actuator may bea screw actuator, such as the actuator shown in any of U.S. Pat. No.2,831,363 to Lohr, U.S. Pat. No. 3,128,634 to Eastman, U.S. Pat. No.5,154,091 to Bianco, U.S. Pat. No. 6,321,611 to Szu; or may be ahand-operated pneumatic actuator, such as the one shown by U.S. Pat. No.5,980,528 to Salys, and the like.

The support bracket 31, to which pulleys 29 and 30 are rotatablymounted, may itself be pivotally mounted to the sole 20 of shoe 10 ataxis 31P (FIGS. 3 and 5 ). The support bracket 31 may be releasablysecured at a suitable angular Θ with respect to an axial direction 39(lengthwise direction) of the shoe, to provide a desired adduction anglefor the traction applied to the toe. The angular orientation of thebracket 31 may be releasably secured using a wing nut 32. Matchingradial serrations may also be used on the bracket 31 and the sole 20, toreduce the torque that may be needed for the wing nut 32 to releasablysecure the bracket to the sole, particularly at greater abductionangles.

FIGS. 6-8 show a shoe embodiment 100 constructed similar to theembodiment of FIGS. 3-5 , but which does not utilize the tension meter.

FIGS. 9-10 show a shoe embodiment 200 of the present inventionconstructed similar to the embodiment of FIGS. 6-8 , in which auniversal joint 231 is utilized to permit more complex adjustments tothe orientation of the strand 228. The universal joint may be the sameas, or be similar to, the universal joint taught by U.S. Pat. No.5,062,730 to Tomii.

FIG. 11 shows a shoe embodiment 300 of the present invention constructedsimilar to the embodiment of FIGS. 3-5 , in which a universal joint 331is utilized to permit more complex adjustments to the orientation of thestrand 328. The universal joint may be the same as, or be similar to,the universal joint taught by U.S. Pat. No. 5,062,730 to Tomii.

FIG. 12 shows a shoe embodiment 400 of the present invention, in which apair of flaps (423F1 and 423F2)—one extending from each side of theshoe- and a pair of top straps 423S1 and 423S2 may be used to secure theshoe with respect to the top of the patient's foot. The straps 423S1 and423S2 may be releasably coupled across to the other side of the shoeusing Velcro.

FIG. 16 shows a shoe embodiment 500 of the present invention that maycompactly incorporate hardware components into a front portion of theshoe, to accomplish traction of a toe therein. Shoe 500 may have one ormore ankle straps 524 and one or more top straps (e.g., 524T1 and524T2), to secure the patient's foot within the shoe, the top of whichmay otherwise be generally open. Shoe 500 may have a spool 550 rotatablymounted at 551 to the sole 520. The end of strand 528 of the toe trap527 may be coupled to the spool 550, so that rotation of the spool maycause the strand to slowly be coiled thereon, and increase the tractionforce applied to the toe. Incremental increases in the traction forcefrom the coiling of the strand 528 on the spool 550 may be accommodatedby the use of the ratchet arrangement similar to the one disclosed byU.S. Pat. No. 3,109,314 to Morisawa.

A toothed ratchet wheel 555 may be concentrically mounted to the spool550. Clockwise movement of the spool may generally be prevented by arelease arm 560. The release arm 560 may be pivotally mounted to thesole 520 of the shoe, and its engagement end 560E may engage any one ofthe teeth of the ratchet wheel 555, and may be prevented from clockwiserotation, along with the ratchet wheel, by contact with stop 565, whichmay protrude up from the sole 520. A torsion spring may normally biasthe engagement end 560E of the release arm 560 into contact with thestop 565.

A finger actuable lever 550L may extend from one side of the spool 550.A patient's finger may thereby apply a force to the lever 550L so thatit may be moved away from the toe, to cause joint rotation of the spool550 and ratchet wheel 555, so that the curved (cam) side of one or moresuccessive teeth of the ratchet wheel may drive the engagement end 560Eof the release arm 560 to pivot counterclockwise, and incrementallyincrease the tension in the strand 528. This increased tension in thestrand 528 would cause an increase in the traction force applied to thetoe. Once the force is removed from lever 550L, the tension in thestrand 528 would cause the spool and ratchet wheel to rotate clockwise,which may occur only briefly, until the flat side of the nearest toothof the ratchet wheel engages with the engagement end 560E of the releasearm 560 and causes it to rotate clockwise until contacting stop 565.

The diameter of the spool that takes up (i.e., coils) the strand 528 maybe smaller than the diameter at which the lever 550L is coupled thereto,to step down the take up thereby provided. This may permit for verysmall changes in the amount of the strand that is taken up by thedisplacement of the lever 550L, so that small incremental increases intraction may be provided to the patient's toe. This would also require asignificant plurality of teeth on the ratchet wheel, to accommodate thesmall incremental changes to the strand tension/toe traction force.

It may be desirable to apply up to approximately 10 kilograms (22pounds) of traction force to the toe, so the components of shoe 500would need to be constructed to safely accommodate the resulting loads.Furthermore, the number of teeth used on the ratchet wheel 555, the rootdiameter of the teeth, and at least the degree of elasticity that may beinherent to the material utilized for the strand 528, may be coordinatedand calibrated so that each successive tooth that may be captured by theengagement end 560E of the release arm 560 may add a small incrementalamount of tension to the strand, which may be in the range of 0.1kilograms to 0.5 kilograms, and may preferably be in the range of 0.2kilograms (0.55 pounds) to 0.3 kilograms. To accomplish small changes tothe tension in the cable, a fine to very fine set of teeth may be usedon the ratchet wheel. The effect of the number of teeth formed on theratchet wheel upon its rotation angle when limited by a pawl may be seenin the following chart:

24 Teeth 15 Degrees per tooth  36 Teeth 10 Degrees per tooth  45 Teeth 8Degrees per tooth 60 Teeth 6 Degrees per tooth 72 Teeth 5 Degrees pertooth 80 Teeth 4.5 Degrees per tooth   100 Teeth  3.6 Degrees pertooth  

Therefore, to accomplish small changes to the tension in the cable, thenumber teeth used on the ratchet wheel may preferably be at least 45 or60 teeth, and more preferably may be 72 teeth or 80 teeth, and mostpreferably may be 100 teeth.

After the user has applied traction to the toe for a recommended periodof time, and desires to remove the shoe 500, a small force may beapplied to lever 550L, being just sufficient so that a tooth of theratchet wheel 555 no longer engages and drives the engagement end 560Eof the release arm 560 into contact with stop 565. The release end 560Rof the release arm 560 may then be actuated so that the engagement end560E of the release arm 560 moves clear of the ratchet wheel 555, andupon releasing of the force applied to the lever 550L, the tension inthe strand 528 may thereby be released, and the toe trap 527 may beremoved from the patient's toe.

FIG. 17 shows a shoe embodiment 600 of the present invention. For shoe600, the ratchet wheel and levers 655 may be constructed substantiallythe same as shown by U.S. Pat. No. 7,374,152 to Ruan. The spool 650 maybe positioned the same as it was for shoe 500, or instead, it may bemore centrally positioned with respect to the lateral extent of theuser's foot, as seen in FIG. 17 , and the strand 628 of the toe trap 627may wrap around a portion of a pulley 601 before being received onto thespool 650 of the ratchet 655. The ratchet 655 for shoe 600 may not befixedly secured to the sole 620, and instead a tension meter 675 may befixedly secured to the sole, and a cable may connect an end of theratchet being distal from the spool 650, with the tension meter. Thescale of the tension meter 675 may be oriented so that it may be easilyread by the patient seeking to apply traction to his or her toe, or itmay be at an orientation that would enable a practitioner to easily readthe scale.

FIG. 18 shows a shoe embodiment 700 of the present invention. Shoe 700may be constructed similar to shoe 600, except that the ratchet assemblymay not include an integral handle to actuate the ratchet wheel, andinstead, a separate handle 770, as seen in FIG. 18A, may be used. Theend 771 of the handle 770 may be inserted into the corresponding opening755A of the wheel, and the handle may be turned like a crank to actuatethe wheel.

FIG. 19 shows a shoe embodiment 800 of the present invention. Shoe 800may be constructed similar to shoe 600, except that the pulley 801 maybe mounted to an actuator 880, using a universal joint. The actuator 880may be a ball screw actuator, or any other similar type of actuatorconfigured to provide linear motion, and may be constructed similar tothe axial actuator of U.S. Pat. No. 4,938,090 to Brusasco. Actuator 880may have a shaft 881, the ends of which may be rotatably supported bysupports 882 and 883, which may protrude up from sole 820. The shaft mayinclude threading between the supports 882 and 883, and a knob 884 atone end. The knob 884 may be actuated to rotate the shaft 881 to drivethe universal joint 885, which may be threadably coupled thereto. Thestrand 828 being looped about the pulley 801 may prevent the universalpoint 885 from co-rotating with the rotating shaft 881, so that therelative movement of the threaded connection therebetween may causetranslation of the universal joint in a desired direction. Thistranslation may be used to set a desired adduction angle for the tensionapplied to the toe using the toe trap 827.

FIG. 19A shows a shoe embodiment 800′ of the present invention. Shoe800′ may be constructed similar to shoe 800, except that rather thanusing a ratchet to add tension to the cable, the end of the cable (whichmay include a tension meter) may instead be actuated by a linearactuator (e.g., any of the actuators disclosed herein). The embodimentmay provide for a compact arrangement with the cable being directed bythe pulley to be at an angle comparable to that formed by at front ofthe foot, by the decreasing size/positioning of the toes.

FIG. 20 shows a shoe embodiment 900 of the present invention. Shoe 900may be constructed similar to shoe 800, except that the support posts982 and 983 that rotatably support the shaft 981 may protrude upwardfrom a plate 995. The plate may be configured to be adjusted up or downwith respect to the sole 920 using a second linear actuator 996, to makean elevational adjustment to the pulley relative to the sole, andthereby set a desired dorsiflexion or plantarflexion angle for thetraction provided to the toe by said cable.

FIG. 21 shows a shoe embodiment 1000 of the present invention. Shoe 1000may incorporate aspects of the shoe embodiment 500 shown in FIG. 16 ,and aspects of the shoe embodiment 900 shown in FIG. 20 . As with shoe500, the shoe 1000 may have a toothed ratchet wheel 1055 concentricallymounted to a spool 1050, except that the ratchet 1055 may be driven byan integral tension wrench 1099 that may be constructed similar to thewrench shown in U.S. Pat. No. 2,256,478 to Hill, which has an integraltension meter upwardly disposed thereon. In addition, rather thanmanually actuating such a wrench, a rotary actuator may instead be usedto precisely apply an amount of torque to the strand 1028 of trap 1027,which produces the desired traction force. The rotary actuator may beconstructed in accordance with the teachings known in this art,including, but not limited to, those of U.S. Pat. No. 5,363,025 toColling for “Actuator Employing Unidirectional Motor for BidirectionalRotational Positioning; U.S. Pat. No. 5,650,704 to Pratt for “ElasticActuator for Precise Force Control”; and U.S. Pat. No. 5,368,112 toMount for “Tensioning Apparatus for Tie Down Lines.” In addition, ratherthan manually actuating the shaft 1081 of the ball screw actuatorarrangement to adjust the abduction angle, as with knob 984 for shoe900, a rotary actuator 1084 may instead be used to move the universaljoint laterally in either direction. Furthermore, it should beunderstood that any of the actuators that may be utilized by thisinvention may be take any suitable form, and may include, but not belimited to, pneumatic actuators, hydraulic actuators, electricactuators, etc., any of which may include tension gauges thereon.

FIGS. 22-29 show a traction apparatus 1100 of the present invention.Apparatus 1100 may have a plate 1105 to which a shoe 1110 may be fixedlysecured. The bottom of the plate 1105 may have one or more platforms1111 that may be used to elevate the plate above the floor. Althoughthere are only two platforms 1111 shown throughout the figures,additional platforms may also be used, or alternatively, a singleplatform that may extend around a substantial portion of the peripheryof the plate 1105 may instead be used to elevate the plate 1105.

A support bracket 1131 may be pivotally mounted to the bottom of theplate 1105, using, for example, the rod 1132 shown in the exploded viewof FIG. 24 . A wing-nut 1133 may be threaded onto the rod to secure thearm 1132 thereto. Applying a sufficient amount of torque to the wing-nut1133 may also serve to releasably secure the angular orientation of thearm with respect to the shoe. Alternatively, a block 1106 and/or aflexible cylindrical member 1107 may be interposed between the bottom ofthe plate 1105 and the wing-nut, which may serve to generally allow thearm to remain pivotally secured to the plate, without restricting itsangular positioning. In this case, a bolt and a second wingnutcombination 1134 may be used to releasably secure the angularpositioning of the arm 1131 with respect to the plate 1105, as seen inFIG. 22 , with the bolt being received through a semi-circular opening1105C in the plate 1105, which may be seen in FIG. 24 . Instead of thesemi-circular opening, a plurality of individual holes may be positionedthereat, which would require removal of the bolt for repositioning ofthe arm. A secondary platform 1112 (FIG. 22 ) may be used to support thearm 1131.

The arm 1131 may have a 90 degree bend formed therein, to create avertical arm portion 1131V. The strand of a toe trap may be secured toan adjustment plate 1136, using any of the means previously disclosedherein. A slot 1131S in the vertical arm portion 1131V of the arm 1131may permit the adjustment plate 1136 to be releasably and adjustablysecured thereto using a bolt and a wing-nut combination 1136B. Theadjustment plate 1136 may thus be moved and secured to any desiredelevated position with respect to the sole of the shoe 1110, to providefor application of traction to the toe at a desired dorsiflexion angle,in addition to a desired adduction angle. The adjustment plate 1136 isshown in FIG. 26 secured at a lower position on the vertical arm portion1131V of the arm 1131, and is shown at a more elevated position withrespect to the vertical arm portion within FIG. 27 .

This embodiment, as with other embodiments described hereinabove, is notrestricted to use for only one foot or the other (i.e., only the leftfoot, or only the right foot), as the design is universal, and isadjustable for use with either foot, as the arm 1131 may be pivoted andsecured to provide a desired adduction angle for any toe for the leftfoot or the right foot (FIGS. 28-29 ).

FIGS. 30-31 show a traction apparatus 1200 of the present invention,which may be constructed the same as apparatus 1100, but mayadditionally include a modified C-clamp 1250. The bottom leg 1251 of theclamp 1250 may be received within a cylindrical member 1207, which maybe a rigid member. The bottom leg 1251 may be releasably secured theretousing the wing-nut 1233, and may pivot about the rod, the same as doesthe arm 1231. A threaded shaft 1255 may be threadably received withinthe upstanding leg 1252 of the clamp 1250, and may be advanced usingknob 1256 until a padded end 1257 is moved into contact against themetatarsal head of the great toe, to impart a lateral force thereat. Thelateral force applied by the padded end 1257 of the threaded shaft 1255may work in combination with the force applied by the toe trap at theadduction angle provided by the particular angular orientation of thearm 1231.

FIGS. 32-33 show a traction apparatus 1300 of the present invention,which may be constructed to operate similar to apparatus 1200, and mayinclude a block 1350 that is configured to be selectively positionedwith respect to the sole of the shoe (which may be oversized). The block1350 may be padded and may be made of a high density plastic. As seen inFIG. 32 , the block 1350 may be shaped to include a vertical surface andan angled surface. The vertical surface, as positioned in FIG. 32 , maybe used to impart a lateral force upon the head of the first metatarsalbone. The block 1350 is shown rotated 180 degrees in FIG. 33 andrepositioned, so that the angled surface may be used to impart rotationto the proximal phalangeal bone of the great toe, which may restthereon, and may augment use of the clamp, which is not shown therein.An additional strap may be used across the top of the shoe, where theblock is positioned.

The positioning of the block 1350 may be accomplished by having one ormore pegs protrude from the bottom of the block, which may be receivedwithin one or more of a plurality of corresponding openings formed in a“pegboard” in roughly the front one-third of the sole of the shoe, asseen in FIG. 34 . To permit greater freedom and flexibility with respectto the positioning of the block 1350, hook and loop fastening materials(i.e., Velcro®) may be used on the bottom of the block and on the soleof the shoe, instead of the peg and pegboard.

The examples and descriptions provided merely illustrate severalembodiments of the present invention. Those skilled in the art andhaving the benefit of the present disclosure will appreciate thatfurther embodiments may be implemented with various changes within thescope of the present invention. Other modifications, substitutions,omissions and changes may be made in the design, size, materials used orproportions, operating conditions, assembly sequence, or arrangement orpositioning of elements and members of the preferred embodiment withoutdeparting from the spirit of this invention.

What is claimed is:
 1. An apparatus configured to apply traction to abig toe of a patient's foot at a desired adduction angle, for use intreating a bunion, said apparatus comprising: a shoe portion, said shoeportion comprising: a sole, said sole configured to support a bottom ofthe patient's foot; and means for releasably securing the patient's footto said sole; a toe trap, said toe trap configured to releasably secureto the big toe of the patient's foot; a mechanism configured to apply anamount of tension to said toe trap relative to said shoe portion, totension the big toe of the patient's foot at a desired adduction angle;a block, said block comprising: a first surface, a second surface, and athird surface; wherein said second surface is formed at an acute angleto said first surface; and wherein said third surface is formed at abouta ninety-degree angle to said first surface; wherein said blockcomprises a piece of hook material fixedly secured to said firstsurface; wherein said sole comprises a piece of loop material; andwherein said hook material on said block is releasably securable to saidloop material on said sole to selectively position said block withrespect to said sole, to contact and apply a force to the metatarsalhead of the big toe of the patient's foot to cooperate with said tensionapplied to the big toe of the patient's foot at the desired adductionangle.
 2. The apparatus according to claim 1, wherein said block isconfigured to occupy a first position with respect to said sole of saidshoe portion; and wherein said second surface, with said block in saidfirst position, is configured to impart rotation to the proximalphalangeal bone of the great toe.
 3. The apparatus according to claim 2,wherein said block is configured to occupy a second position withrespect to said sole of said shoe portion; and wherein said thirdsurface, with said block in said second position, is configured toimpart a lateral force upon the metatarsal head of the big toe.
 4. Theapparatus according to claim 1, further comprising a meter configured toindicate said amount of tension.
 5. An apparatus configured to applytraction to a big toe of a patient's foot at a desired adduction angle,for use in treating a bunion, said apparatus comprising: a shoe portion,said shoe portion comprising: a sole, said sole configured to support abottom of the patient's foot; and means for releasably securing thepatient's foot to said sole; a toe trap, said toe trap configured toreleasably secure to the big toe of the patient's foot; a mechanismconfigured to apply an amount of tension to said toe trap relative tosaid shoe portion, to tension the big toe of the patient's foot at adesired adduction angle; a block, said block comprising: a firstsurface, a second surface, and a third surface; wherein said secondsurface is formed at an acute angle to said first surface; and whereinsaid third surface is formed at about a ninet_(y)=degree angle to saidfirst surface; wherein said block comprises a peg configured to protrudefrom said first surface; wherein said sole comprises a plurality ofopenings, each configured to releasably receive said peg to selectivelyposition said block with respect to said sole, to contact and apply aforce to the metatarsal head of the big toe of the patient's foot withsaid second surface or said third surface to cooperate with said tensionapplied to the big toe of the patient's foot at the desired adductionangle.
 6. The apparatus according to claim 5, wherein said block isconfigured to occupy a first position with respect to said sole of saidshoe portion; and wherein said second surface, with said block in saidfirst position, is configured to impart rotation to the proximalphalangeal bone of the great toe.
 7. The apparatus according to claim 6,wherein said block is configured to occupy a second position withrespect to said sole of said shoe portion; and wherein said thirdsurface, with said block in said second position, is configured toimpart a lateral force upon the metatarsal head of the big toe.
 8. Theapparatus according to claim 5, further comprising a meter configured toindicate said amount of tension.
 9. An apparatus configured to applytraction to a big toe of a patient's foot at a desired adduction angle,for use in treating a bunion, said apparatus comprising: a plate, saidplate configured to support a bottom of the patient's foot; means forreleasably securing the patient's foot to said plate; a toe trap, saidtoe trap configured to releasably secure to the big toe of the patient'sfoot; a mechanism configured to apply an amount of tension to said toetrap relative to said plate, to tension the big toe of the patient'sfoot at a desired adduction angle; a block, said block comprising: afirst surface, a second surface, and a third surface; wherein saidsecond surface is formed at an acute angle to said first surface; andwherein said third surface is formed at about a ninety degree angle tosaid first surface; means for releasably positioning said block on saidplate for applying a force to the big toe of the patient's foot withsaid second surface or said third surface to cooperate with said tensionapplied to the big toe of the patient's foot at the desired adductionangle.
 10. An apparatus configured to apply traction to a big toe of apatient's foot at a desired adduction angle, for use in treating abunion, said apparatus comprising: a sole, said sole configured tosupport a bottom of the patient's foot; means for releasably securingthe patient's foot to said sole; a toe trap, said toe trap configured toreleasably secure to the big toe of the patient's foot; means forapplying an amount of tension to said toe trap relative to said sole,for tensioning the big toe of the patient's foot at a desired adductionangle; a block, said block comprising: a first surface, a secondsurface, and a third surface; wherein said second surface is formed atan acute angle to said first surface; and wherein said third surface isformed at about a ninety-degree angle to said first surface; means forselectively positioning and securing said block with respect to saidsole, for applying a force to the metatarsal head of the big toe of thepatient's foot to cooperate with said tension applied to the big toe atthe desired adduction angle.
 11. The apparatus according to claim 10,wherein said block is configured to occupy a selective position withrespect to said sole; and wherein when said block is in said selectiveposition, said second surface is configured to impart rotation to theproximal phalangeal bone of the great toe.
 12. The apparatus accordingto claim 10, wherein said block is configured to occupy a selectiveposition with respect to said sole; and wherein when said block is insaid selective position, said third surface is configured to impart alateral force to the metatarsal head of the big toe.
 13. The apparatusaccording to claim 10, further comprising a meter configured to indicatesaid amount of tension.